FDA.reportPublic FDA data

Application 204680

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-291Hydralazine Hydrochloridehydralazine hydrochlorideMylan Institutional LLCANDACurrent
67457-291Hydralazine Hydrochloridehydralazine hydrochlorideMylan Institutional LLCANDACurrent
71872-7052Hydralazine Hydrochloridehydralazine hydrochlorideMedical Purchasing Solutions, LLCANDACurrent